New Suture for Valve Surgery Cleared by FDA

A new suture for use in heart-valve surgery has been cleared by the U.S. Food and Drug Administration (FDA). The suture is designed to make valve surgery simpler and less traumatic.

Called NextStitch, the suture incorporates two suture strands into each needle, allowing surgeons to simultaneously drive two suture strands through the same needle hole. By placing two suture strands with each needle, surgeons will now be able to implant a prosthetic heart valve with about half the number of needle passes as they would when using a conventional valve suture.

Fewer needle passes are expected to make valve surgery faster and more efficient, potentially reducing both the complexity and cost of the procedure. Also, fewer needle punctures means less trauma to the annulus. In addition, NextStitch does not require the surgeon to place each needle very close to the adjacent suture, making needle placement easier and avoiding the risk of damaging a suture with an adjacent needle.

NextStitch is the product of Genzyme Surgical Products (Cambridge, MA, USA), a leading provider of specialty surgical devices for the cardiothoracic market. "With NextStitch, we have the opportunity to increase our leadership position in the valve suture market,” said J. Patrick Mackin, vice president of cardiothoracic surgery for Genzyme Surgical Products.



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